Rotational atherectomy device

ABSTRACT

An atherectomy device for removing tissue from an artery. The device includes a flexible, elongated drive shaft rotatable about a guide wire, the drive shaft having an enlarged diameter tissue removal section. The drive shaft and the enlarged diameter tissue removal section are comprised of helically wound wire. Wire turns of the proximal portion of the tissue removal section have diameters that gradually increase distally at a generally constant rate thereby forming generally the shape of a cone. Wire turns of the distal portion of the enlarged diameter tissue removal section have diameters that gradually decrease distally thereby forming a generally convex distal portion. At least part of the tissue removal section includes an external coating of an abrasive material to define an abrasive segment of the drive shaft. The drive shaft may include a reduced diameter segment located near the enlarged diameter tissue removal section to facilitate smooth rotation of the drive shaft and its tissue removal section about the guide wire when the atherectomy device is rotated at high speeds. Preferably such a reduced diameter segment is provided just proximal to the enlarged diameter tissue removal section, and preferably the entire portion of the drive shaft distal to the enlarged diameter tissue removal section also has a similarly reduced diameter. The maximum outer diameter and length of the abrasive segment may be selected so that, at operational rotational speeds and under load, at least some of the wire turns of the proximal portion of the enlarged diameter tissue removal section unwind from their at-rest diameter to an effective outer diameter which is the same as or larger than the maximum outer diameter of the abrasive segment.

TECHNICAL FIELD

The invention relates to devices and methods for removing tissue frombody passageways, such as removal of atherosclerotic plaque fromarteries, utilizing a rotational atherectomy device.

BACKGROUND OF THE INVENTION

A variety of techniques and instruments have been developed for use inthe removal or repair of tissue in arteries and similar bodypassageways. A frequent objective of such techniques and instruments isthe removal of atherosclerotic plaques in a patient's arteries.Atherosclerosis is characterized by the buildup of fatty deposits(atheromas) in the intimal layer (under the endothelium) of a patient'sblood vessels. Very often over time, what initially is deposited asrelatively soft, cholesterol-rich atheromatous material hardens into acalcified atherosclerotic plaque. Such atheromas restrict the flow ofblood, and therefore often are referred to as stenotic lesions orstenoses, the blocking material being referred to as stenotic material.If left untreated, such stenoses can cause angina, hypertension,myocardial infarction, strokes and the like.

Several kinds of atherectomy devices have been developed for attemptingto remove some or all of such stenotic material. In one type of device,such as that shown in U.S. Pat. No. 4,990,134 (Auth), a rotating burrcovered with an abrasive cutting material such as diamond grit (diamondparticles or dust) is carried at the distal end of a flexible driveshaft. The rotating burr is rigid and inflexible, however, makingnavigation around tight bends or curves in an artery more difficult, andmaking the removal of stenotic lesions in such bends or curves equallydifficult.

U.S. Pat. No. 5,314,438 (Shturman) shows another atherectomy devicehaving a drive shaft with a section of the drive shaft having anenlarged diameter, at least a segment of this enlarged diameter sectionbeing covered with an abrasive material to define an abrasive segment ofthe drive shaft. When rotated at high speeds, the abrasive segment iscapable of removing stenotic tissue from an artery. In some of theembodiments depicted in the Shturman patent, wire turns of the enlargeddiameter segment of the drive shaft are supported by a bushing. Eventhough this bushing may be made of a flexible material, nevertheless itdecreases somewhat the flexibility of the enlarged diameter abrasivesegment of the drive shaft.

Unless a bushing within the enlarged diameter section is utilized,Applicants have found that adjacent wire strands of this section canfall out of alignment with one another when the enlarged diameterportion of the drive shaft is bent around a curve of a relatively smallradius.

SUMMARY OF THE INVENTION

The invention provides an atherectomy device comprised of a flexible,elongated drive shaft having an enlarged diameter tissue removal sectionwhich retains substantial flexibility while reducing the tendency of thewire turns to fall out of alignment with one another. The tissue removalsection of the drive shaft of this atherectomy device includes proximaland distal portions comprised of helically wound wire, wire turns of theproximal portion of the tissue removal section having diameters thatprogressively increase distally at a generally constant rate therebyforming generally the shape of a cone. Wire turns of the distal portionof the enlarged diameter tissue removal section have diameters thatgradually decrease distally thereby forming a generally convex distalportion.

The conical shape of the proximal portion of the tissue removal sectionsubstantially reduces the tendency of the wire turns to fall out ofalignment with one another, without the need to utilize a bushing,thereby preserving substantial flexibility in the enlarged diametersection.

At least part of the tissue removal section includes an external coatingof an abrasive material, secured to the wire turns of the drive shaft bya suitable binder, to define an abrasive segment of the drive shaft.Preferably the binder also secures some of the adjacent wire turns ofthe tissue removal section to one another, most preferably throughout adistal portion of the tissue removal section.

In a preferred embodiment, the drive shaft of the atherectomy deviceincludes a reduced diameter segment, such segment being located near thetissue removal section of the drive shaft to function as a bearing forrotation of the drive shaft about a guide wire. The reduced clearancebetween the guide wire and the inner surface of the reduced diametersegment is less than in other portions of the drive shaft and isintended to reduce vibrations of the tissue removal section andfacilitate smooth rotation of the drive shaft and its tissue removalsection about the guide wire when the atherectomy device is rotated athigh speeds. Two or more of such reduced diameter segments may beincluded, preferably at least one being located distally of the tissueremoval section of the drive shaft, and at least one being locatedproximally of the tissue removal section of the drive shaft. Preferablysuch reduced diameter segments are located within about one inch fromthe enlarged diameter tissue removal section, and most preferably withinabout a quarter inch from such tissue removal section.

The maximum outer diameter and length of the abrasive segment of theenlarged diameter tissue removal section may be selected so that, atoperational rotational speeds and under load, at least some of the wireturns of the proximal portion of the enlarged diameter tissue removalsection unwind from their at-rest diameter to an effective outerdiameter which is the same as or larger than the maximum outer diameterof the abrasive segment.

The drive shaft of the atherectomy device may include a distal endsegment having an outer diameter which decreases distally to define agenerally convex outer surface. At least a portion of this distal endsegment may be provided with an external coating of an abrasive materialto define a second abrasive segment at the very distal end of the driveshaft. Such an abrasive coated distal end segment facilitates passage ofthe rotating drive shaft of the atherectomy device across even verytight stenoses.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an atherectomy device of the invention;

FIG. 2 is a broken-away, longitudinal cross-sectional view of theenlarged diameter tissue removal section of the atherectomy device shownin FIG. 1;

FIG. 3 is a broken-away, longitudinal cross-sectional view of theenlarged diameter tissue removal section of a prior art atherectomydevice;

FIG. 4 is a broken-away, longitudinal cross-sectional view of theatherectomy device of FIG. 2 depicted in a slightly curvedconfiguration;

FIG. 5 is a broken-away, longitudinal cross-sectional view of the priorart atherectomy device of FIG. 3 depicted in a slightly curvedconfiguration;

FIG. 6 is a broken-away, longitudinal cross-sectional view of theatherectomy device of FIG. 2 depicted in a more tightly curvedconfiguration;

FIG. 7 is a broken-away, longitudinal cross-sectional view of the priorart atherectomy device of FIG. 3 depicted in a more tightly curvedconfiguration;

FIG. 8 is a broken-away, longitudinal cross-sectional view of a mandrelused in manufacturing a rotational atherectomy device of the invention;

FIG. 9 is a broken-away, longitudinal cross-sectional view of a modifiedembodiment of the invention having a distal end segment coated withabrasive material to define a second abrasive segment at the very distalend of the atherectomy device;

FIG. 9A is an enlarged view of the distal section of the atherectomydevice of FIG. 9;

FIG. 10 is a broken-away, longitudinal cross-sectional view of amodified embodiment of the invention having a distal end segmentpartially coated with abrasive material to define a second abrasivesegment at the very distal end of the atherectomy device;

FIG. 10A is an enlarged view of the distal section of the atherectomydevice of FIG. 10;

FIG. 11 is a broken-away, longitudinal cross-sectional view of amodified embodiment of the invention having a layer of tubing coveringthe section of the drive shaft in between the two abrasive segments ofthe atherectomy device;

FIG. 11A is an enlarged view of the distal section of the atherectomydevice of FIG. 11;

FIG. 12 is a broken-away, longitudinal cross-sectional view of amodified embodiment of the invention having a distal section with adiameter smaller than the diameter of the proximal section of theatherectomy device;

FIG. 12A is an enlarged view of the distal section of the atherectomydevice of FIG. 12;

FIG. 12B is an enlarged view of portions of the proximal section of theatherectomy device of FIG. 12;

FIG. 13 is a broken-away, longitudinal cross-sectional view of amodified embodiment of the invention having a distal section with areduced diameter, and a single reduced diameter segment locatedproximally of the enlarged diameter tissue removal section;

FIG. 13A is an enlarged view of the distal section of the atherectomydevice of FIG. 13;

FIG. 13B is an enlarged view of portions of the proximal section of theatherectomy device of FIG. 13;

FIG. 14 is a perspective view of a clamp used in manufacturing therotational atherectomy device shown in FIG. 13, which has a distalsection with a reduced diameter, and a single reduced diameter segmentlocated proximally of the enlarged diameter tissue removal section;

FIG. 14A is a longitudinal cross-sectional view of the clamp of FIG. 14;

FIG. 14B is an enlarged view showing in longitudinal cross-sectiondetails of a portion of FIG. 14A;

FIG. 15 is an enlarged cross-sectional view, partially broken away, ofFIG. 14A, taken along lines 15--15 thereof;

FIG. 16 is a broken-away, longitudinal cross-sectional view of amodified embodiment of the invention with a distal section having asegment with a reduced diameter, and a similar reduced diameter segmentlocated proximally of the enlarged diameter tissue removal section;

FIG. 16A is an enlarged view of the distal section of the atherectomydevice of FIG. 16;

FIG. 16B is an enlarged view of portions of the proximal section of theatherectomy device of FIG. 16;

FIG. 17 is a broken-away, longitudinal cross-sectional view of amodified embodiment of the invention with a distal section having twosegments with a reduced diameter, and a similar reduced diameter segmentlocated proximally of the enlarged diameter tissue removal section;

FIG. 17A is an enlarged view of the distal section of the atherectomydevice of FIG. 17;

FIG. 17B is an enlarged view of portions of the proximal section of theatherectomy device of FIG. 17;

FIG. 18 is a broken-away, longitudinal cross-sectional view of amodified embodiment of the invention with a distal section having twosegments with a reduced diameter, and two similar reduced diametersegments located proximally of the enlarged diameter tissue removalsection;

FIG. 19 is a broken-away, longitudinal cross-sectional view of amodified embodiment of the invention similar to FIG. 13, but wound froma single strand of wire;

FIG. 20 is a broken-away, longitudinal cross-sectional view of anatherectomy device of the invention, showing both the extent of coverageby the abrasive material of the enlarged diameter tissue removal sectionof the rotational atherectomy device, and a moved position of the wireturns of the enlarged diameter tissue removal section of the device whenthe wire turns are unwinding under load;

FIG. 21 is a broken-away, longitudinal cross-sectional view of anotherembodiment of an atherectomy device similar to FIG. 20, the wire turns,in their moved position, being depicted as unwinding to a slightlylarger diameter;

FIG. 22 is a broken-away, longitudinal cross-sectional view of anatherectomy device similar to FIG. 20, with the proximal end of theabrasive segment terminating at the maximum diameter of the enlargeddiameter tissue removal section;

FIG. 23 is a broken-away, longitudinal cross-sectional view of anatherectomy device similar to FIG. 21, with the proximal end of theabrasive segment terminating at the maximum diameter of the enlargeddiameter tissue removal section;

FIG. 24 is a broken-away, longitudinal cross-sectional view of anatherectomy device of the invention, with the proximal end of theabrasive segment terminating distally of the maximum diameter of theenlarged diameter tissue removal section;

FIG. 25 is an enlarged longitudinal cross-sectional view of a portion ofa rotational atherectomy device of the invention, illustrating changesin the longitudinal cross-sectional profile of its enlarged diametertissue removal section;

FIG. 26 is a broken-away, longitudinal cross-sectional view of anotheratherectomy device of the invention, illustrating a slightly differentprofile of the enlarged diameter tissue removal section;

FIG. 27 is an enlarged view of a portion of the atherectomy device ofFIG. 26, illustrating the changes in the longitudinal cross-sectionalprofile of its enlarged diameter tissue removal section;

FIG. 28 is a broken-away, longitudinal cross-sectional view of anotheratherectomy device of the invention, illustrating a different profile ofthe enlarged diameter tissue removal section;

FIG. 29 is a broken-away, longitudinal cross-sectional view of anotheratherectomy device of the invention, illustrating yet another profile ofthe enlarged diameter tissue removal section;

FIGS. 30A and 30B are broken-away, longitudinal cross-sectional views ofatherectomy devices of the invention, illustrating proportionality ofsuch devices of different sizes;

FIGS. 31A and 31B are broken-away, longitudinal cross-sectional views ofatherectomy devices of the invention, each having a distal end segmentcoated with abrasive material to define a distal end abrasive segment;

FIG. 32 is a broken-away, longitudinal cross-sectional view of a distalsection of a modified atherectomy device of the invention with wireturns of the distal section having a thin external coating of aradio-opaque material;

FIG. 33 is a broken-away, longitudinal cross-sectional view of a distalsection of a modified embodiment similar to FIG. 32, but with theradio-opaque material coating the entire circumference of wire turns inthe distal section of the atherectomy device;

FIG. 34 is a broken-away, longitudinal cross-sectional view of a distalsection of another modified embodiment similar to FIG. 33, but with theradio-opaque material coating all but the inner surface of wire turns inthe distal section of the atherectomy device;

FIG. 35 is a broken-away, longitudinal cross-sectional view of a distalsection of a modified atherectomy device of the invention with thedistal end encapsulated by a generally cylindrical ring made from aradio-opaque material;

FIG. 36 is a broken-away, longitudinal cross-sectional view of thedistal section of a modified atherectomy device of the invention withthe distal end rounded off;

FIG. 37 is a broken-away, longitudinal cross-sectional view of theembodiment of FIG. 36 with the distal end coated with a bonding materialto secure the wire turns to one another;

FIG. 38 is a broken-away, longitudinal cross-sectional view of thedistal section of a modified atherectomy device of the invention withthe distal end trimmed off "square";

FIG. 39 is a broken-away, longitudinal cross-sectional view of theembodiment of FIG. 38 with the distal end coated with a bonding materialto secure the wire turns to one another;

FIG. 40 is a broken-away, longitudinal cross-sectional view of thedistal section of a modified atherectomy device of the invention withthe distal end electroplated before being trimmed to its finishedlength;

FIG. 41 is a broken-away, longitudinal cross-sectional view of theembodiment of FIG. 40 with the distal end trimmed to its finishedlength;

FIG. 42 is a broken-away, longitudinal cross-sectional view of amodified embodiment of the invention having a drive shaft with twodistally tapered segments; and

FIG. 43 is a broken-away, longitudinal cross-sectional view of a mandrelused in manufacturing the atherectomy device of FIG. 42.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a typical rotational atherectomy device of theinvention. The device includes a handle portion 10, an elongated,flexible drive shaft 20 having an enlarged diameter tissue removalsection 28, and an elongated catheter 13 extending distally from thehandle portion 10. The drive shaft 20 is constructed from helicallycoiled wire, preferably multifilar. The catheter 13 has a lumen in whichmost of the length of the drive shaft 20 is disposed, the enlargeddiameter tissue removal section 28 extending distally beyond the distalend of the catheter 13. The drive shaft 20 also contains an inner lumen,permitting the drive shaft 20 to be advanced and rotated over a guidewire 15.

The handle 10 desirably contains a turbine (or similar rotational drivemechanism) for rotating the drive shaft 20 at high speeds. The handle 10typically may be connected to a power source (such as compressed air), asource of physiologic solution (used for cooling and lubrication),through suitable tubing, which are not illustrated for the sake ofclarity (details regarding such handles and associated instrumentationare well know in the industry, and are described, e.g., in U.S. Pat. No.5,314,407, issued to Auth). The handle 10 also desirably includes acontrol knob 11 for advancing and retracting the turbine and drive shaft20 with respect to the catheter 13 and the body of the handle.

FIG. 2 shows more details of the enlarged diameter tissue removalsection 28. The section 28 includes proximal and distal portions. Wireturns 31 of the proximal portion 30 of the tissue removal section 28have diameters that progressively increase distally at a generallyconstant rate, thereby forming generally the shape of a cone. Theconical shape of the proximal portion 30 of the tissue removal section28 gives desirable performance characteristics, which will be discussedin greater detail below. Wire turns of the distal portion 40 havediameters that gradually decrease distally (preferably at a varyingrate) thereby forming a generally convex distal portion 40.

At least part of the tissue removal section 28 (preferably the distalportion 40 of the tissue removal section 28) includes an externalcoating of an abrasive material 24 to define an abrasive segment of thedrive shaft 20. The abrasive material may be any suitable material, suchas diamond powder, fused silica, titanium nitride, tungsten carbide,aluminum oxide, boron carbide, or other ceramic materials. Preferablythe abrasive material is comprised of diamond chips (or diamond dustparticles) attached directly to the wire turns of the drive shaft 20 bya suitable binder 26--such attachment may be achieved using well knowntechniques, such as conventional electroplating or fusion technologies(see, e.g., U.S. Pat. No. 4,018,576).

Preferably a portion of the drive shaft 20 proximal to the enlargedtissue removal section 28 is encased in a thin, flexible, low frictionsheath or coating 22. In a preferred embodiment, the sheath or coating22 is sufficiently long so that its proximal end remains disposed insidethe catheter 13 even when the drive shaft 20, with its enlarged diametertissue removal section 28 is fully advanced distally with respect to thecatheter 13. Applicants have successfully utilized heat shrinkablepolytetrafluoroethylene tubing to make such sheath 22. Such sheath orcoating 22 may be made from other suitable materials.

FIG. 3 depicts an enlarged diameter tissue removal section 28' of aprior art atherectomy device similar to that described in U.S. Pat. No.5,314,438 (Shturman). In both FIGS. 2 and 3, the enlarged diametertissue removal sections 28 and 28' are shown in a generally straight(i.e., "at rest") configuration.

FIGS. 4 and 5 illustrate the differences in certain performancecharacteristics of the atherectomy device of the invention in comparisonto the prior art device. In these figures, each of the devices has beenbent into a curved configuration with a radius of curvature which isrelatively large. Each of the devices is illustrated as beingconstructed from tri-fiar helical windings of wire, and all but theabrasive segments of both devices are generally flexible.

Notice that in FIG. 5 (the prior art version), adjacent windings in theproximal portion of the enlarged diameter section 28' have slipped pastone another, coming out of smooth alignment. This phenomena is not seenin the distal portion of the enlarged diameter section 28' because thebinder used to secure the abrasive particles to the turns of the driveshaft also serves to secure adjacent wire turns to one another, thuskeeping such wire turns in relative alignment with one another.

FIG. 4 illustrates an advantage of the invention over the prior art.Applicants have found that by providing the proximal portion 30 of theenlarged diameter section 28 of the drive shaft 20 with a generallyconical shape, the wire turns 31 tend to stay in alignment as thisportion of the drive shaft is bent into a curved configuration.Alignment of the wire turns 31 in FIG. 4 can easily be compared to themisalignment of the wire turns in FIG. 5 by reference to thehypothetical center lines 32 and 32'. The atherectomy device of FIG. 4illustrates a device having an enlarged diameter tissue removal section28 with a maximum diameter of about 2.1 mm, bent into a curvedconfiguration with a radius of curvature of about 10 mm.

FIGS. 6 and 7 illustrate this effect even more dramatically, as both anatherectomy device of the invention (FIG. 6) and a prior art atherectomydevice (FIG. 7) are bent into a curved configuration with a smallerradius of curvature. The misalignment of wire turns in the prior artdevice (FIG. 7) becomes more severe, while the wire turns of the deviceof the invention (FIG. 6) stay well-aligned. The atherectomy device ofFIG. 6 illustrates a device having an enlarged diameter tissue removalsection 28 with a maximum diameter of about 2.1 mm, bent into a curvedconfiguration with a radius of curvature of about 5 mm.

Helically wound multifilar drive shafts usable in the invention may bemanufactured by winding suitable wires about a mandrel. FIG. 8 depicts amandrel 50 usable to construct the enlarged diameter tissue removalsection 28 of the atherectomy device depicted in FIGS. 2, 4 and 6. Themandrel includes a round central mandrel shaft 52 having a generallyconstant diameter along its entire length. An enlarged portion 54, maybe manufactured from suitable materials. For example, it may be machinedfrom, e.g., brass (such as round brass rod sold by Vincent Metals, ofMinneapolis, Minn. as "low leaded" brass rod comprised of 62.0% copper,36.2% zinc and 1.8% lead, or "high speed--free cutting" brass rodcomprised of 61.5% copper, 35.5% zinc and 3.0% lead). This enlargedportion 54 is disposed on the mandrel shaft 52 at the desired location,and is then secured in place with a suitable material, such as solder56. Preferably the solder composition is 61% tin and 39% lead. Also, theflux used in soldering the enlarged portion 54 to the mandrel shaft 52preferably is comprised of 75% ZnCl₂ and 25% NH₄ Cl, these compoundsbeing dissolved in distilled water at maximum concentration (i.e.,creating a saturated solution). The solder joint may be further machinedor sanded to achieve a desirably smooth transition from the diameter ofthe enlarged portion 54 to the diameter of the mandrel shaft 52.

After the mandrel 50 is so constructed, suitable wires may be woundabout the mandrel shaft 52 and the enlarged portion 54, and the entireunit (or, preferably, just the enlarged diameter tissue removal section28, together with that portion of the drive shaft 20 that is distal tothe enlarged diameter tissue removal section 28 and about 80 mm of thedrive shaft proximal to the enlarged diameter tissue removal section 28)may then be heat treated to give the wire the desired "set." Preferablythe heat treatment is in the range of about 360° C. to about 560° C. forabout one hour to give the wire the desired set. The particulartemperature selected will depend on the type of wire used and themaximum diameter of the enlarged diameter tissue removal section.Applicants have successfully used stainless steel helically wound wirewith a diameter of about 0.006 inches for drive shafts having tissueremoval sections with diameters of about 1.75 mm or less, and about0.007 inches for drive shafts having tissue removal sections withdiameters of about 1.75 mm or more. Applicants have successfully usedstainless steel wire available from Fort Wayne Metals Research ProductsCorp. (Fort Wayne, Ind.) under the names "Spring Temper" and "Hyten"(both being type 304 stainless steel wire).

After the heat treatment has been completed, the mandrel is thenremoved. Because the enlarged portion 54 of the mandrel has a diameterexceeding the diameter of the mandrel shaft 52, the enlarged portion 54of the mandrel 50 must be removed before the remaining portion of themandrel may be withdrawn from within the helically wound drive shaft.Applicants have found that the enlarged portion 54 of the mandrel maysuitably be removed by constructing the mandrel from materials differentfrom the drive shaft wire, and then dissolving at least the enlargedportion 54 of the mandrel 50. For example, the mandrel shaft 52 may bemade from high carbon steel, the enlarged portion 54 from brass (asdescribed above), and the helically wound wire from stainless steel(such as the type 304 Spring Temper or Hyten stainless steel wirementioned above). The enlarged portion 54 of the mandrel (together withthe enlarged diameter tissue removal section 28 as well as that portionof the drive shaft 20 that is distal to the enlarged diameter tissueremoval section and about 50 mm of the drive shaft proximal to theenlarged diameter tissue removal section 28) is then immersed in boilingnitric acid (typically at about 107° C.) ρ=1.33 g/cm³ for, e.g., about15-45 minutes until the entire immersed section of the mandrel(including both the enlarged portion 54 of the mandrel and the immersedsection of the mandrel shaft 52) is completely dissolved. The actualtime it takes to completely dissolve the immersed portion of the mandrel50 depends on the size of the spaces between wire turns of the driveshaft and diameter of the enlarged portion 54 of the mandrel (smallerspaces require longer times, and larger diameters of the enlargedportion 54 of the mandrel require longer times). The drive shaft wiresare not adversely affected by the nitric acid. The remaining proximalportion of the mandrel shaft 52 may then be easily removed. After themandrel shaft 52 is removed, then the entire drive shaft preferably isheat treated at temperatures ranging from 200 to 300° C. to relievestresses in the wire turns of the drive shaft. The drive shaft then isfinished by electropolishing.

FIGS. 9 and 9A depict the entire length of a modified embodiment of theatherectomy device of the invention (including the proximal end portion18 of the drive shaft 20) in which the distal section 60 of the driveshaft 20 (i.e., that portion of the drive shaft 20 which is distal tothe enlarged diameter tissue removal section 28 of the drive shaft 20)includes a distal end segment 64. Desirably at least a portion of thedistal end segment 64 is provided with an external coating of anabrasive material 24' (secured by a suitable binder 26') to define asecond abrasive segment at the distal end of the drive shaft 20. Thissecond abrasive segment preferably has an outer diameter which decreasesdistally to define a generally convex outer surface--preferably theinner diameter of the distal end segment is generally constant, and,thus, it is the cross-sectional thickness of the wire turns of thedistal end segment 64 which decreases distally to form the generallyconvex outer surface of the distal end segment 64 of the drive shaft 20.

The second abrasive segment of the drive shaft 20 enables the rotatingdrive shaft of the atherectomy device to be advanced across even a verytight stenosis. In use, the rotating abrasive segment of the distal endsegment 64 opens the stenosis to a diameter sufficient to permitadvancement of the distal section 60 of the drive shaft 20 across thestenosis until the abrasive material 24 of the enlarged diameter section28 of the drive shaft 20 engages the stenotic material. The enlargeddiameter section 28 then is used to open the stenosis to a diameterequal to (or, due to slight vibrations of the enlarged diameter section28, usually somewhat larger than) the largest outer diameter of theenlarged diameter section 28 of the drive shaft 20.

FIG. 9A shows abrasive material 24' covering essentially all of thedistal end segment 64. FIGS. 10 and 10A depict a slightly modifiedembodiment where the binder material 26' secures adjacent wire turns ofthe distal end segment to one another (as in FIGS. 9 and 9A), butabrasive material 24' covers only a portion of the binder material 26'.

FIGS. 11 and 11A depict an embodiment similar to FIGS. 9 and 9A, butwith the addition of a thin, flexible, low friction sheath or coating 23encasing at least a substantial portion of the distal section 60 betweenthe abrasive material 24 of the enlarged diameter section 28 and theabrasive material 24' of the distal end segment 64. The sheath orcoating 23 covering the substantial portion of the distal section 60 ofthe drive shaft 20 may be made from the same material as the sheath orcoating 22 covering the portion of the drive shaft 20 immediatelyproximal to the enlarged diameter tissue removal section 28. For thispurpose applicants have successfully utilized heat shrinkablepolytetrafluoroethylene tubing.

FIGS. 12-18 depict various embodiments of the atherectomy device of theinvention in which the diameters of certain portions of the drive shaft20 (other than the enlarged diameter tissue removal section 28) arereduced. Reduced diameter segments of the drive shaft 20 can be utilizedto function as a bearing for rotation of the drive shaft about a guidewire. The reduced clearance between the guide wire and the inner surfaceof the reduced diameter segment is less than in other portions of thedrive shaft and is intended to reduce vibrations of the enlargeddiameter section and facilitate smooth rotation of the drive shaft andits enlarged diameter section about the guide wire when the atherectomydevice is rotated at high speeds.

In the embodiment depicted in FIGS. 12, 12A and 12B, the inner and outerdiameters of the distal section 60 of the drive shaft 20 are smallerthan the corresponding inner and outer diameters of the section of thedrive shaft proximal to the enlarged diameter section 28. In FIGS. 13,13A and 13B the inner and outer diameters of the distal section 60 ofthe drive shaft 20 are similarly reduced, and there is also a shortsegment 68, just proximal to the enlarged diameter section 28, which hasreduced inner and outer diameters.

FIGS. 14-15 illustrate the use of a clamp in manufacturing therotational atherectomy device of FIG. 13. The particular clamp shown inFIGS. 14-15 is used to manufacture the specific rotational atherectomydevice depicted in FIG. 13, but it will be understood that variations onthis clamp may be utilized to make any of the various embodimentsdepicted in FIGS. 12-13, as well as FIGS. 17-18, described below.

Referring to FIGS. 14-15, the clamp includes a clamp frame 72 with aslot 73, two sets of clamping blocks 74 and 75, and a pair of set screws78. After the drive shaft wires have been wound about a suitably shapedmandrel (such as the mandrel depicted in FIG. 8) and before the windingtension on the wires has been released, the clamp 72 is secured on thedrive shaft at the appropriate location. This is accomplished by firstpassing the drive shaft through the slot 73 in the clamp frame 72, nextpositioning the clamping blocks 74 and 75 about the drive shaft 20 andmoving them into the clamp frame 72, and finally tightening set screws78 to firmly clench the drive shaft with its enlarged diameter tissueremoval section 28 between the clamping blocks 74 and 75. Once the setscrews 78 are tightened, the winding tension on the drive shaft wiresmay be released. Those portions of the drive shaft wires not captured bythe clamp will unwind to a diameter slightly larger than the mandrel,but the clamp will prevent such unwinding for the entire portion of thedrive shaft located between the two sets of clamping blocks 74 and 75.

FIG. 14A illustrates in longitudinal cross-section how the drive shaft20 is clenched by clamping blocks 74 and 75. In FIGS. 14B and 15 theportions of the drive shaft not captured by the clamp are shown ashaving unwound to a diameter larger than the diameter of the portioncaptured by the clamp. FIGS. 14A and 14B, however, significantlyexaggerate the degree of unwinding--typically the outer diameter of thedrive shaft, as a result of unwinding, will expand only about 1% toabout 10%.

Once the clamp has been secured to the drive shaft and the portions ofthe drive shaft not captured by the clamp are allowed to unwind to aslightly larger diameter, then the section of the drive shaft which isdistal to the enlarged diameter section 28, the enlarged diameter tissueremoval section 28 itself, and about 80 mm of the drive shaft 20proximal to the enlarged diameter tissue removal section 28 are heattreated (as described above) to give the wires of these portions of thedrive shaft the desired "set." After the assembly has cooled, the clampmay be removed. The drive shaft then may be further processed asdescribed above (including removal of the mandrel, second heat treatmentand electropolishing).

The reduced diameter distal section 60 (i.e., the portion of the driveshaft 20 distal to the enlarged diameter section 28) preferably is about10-12 mm long, and may be formed by trimming off the drive shaft 20proximally to the area (or in the area) where the distal set of clampingblocks 75 was located.

Similar techniques can easily be utilized to produce one or more reduceddiameter segments 68 at the desired locations on the drive shaft 20.

FIGS. 16, 16A and 16B depict another rotational atherectomy device inwhich most of the length of the relatively long distal section 60 hasinner and outer diameters equal to the inner and outer diameters of mostof the length of the drive shaft 20, except for a relatively shortreduced diameter segment 68 located just distal to the enlarged diametersection 28. The rest of the atherectomy device depicted in FIGS. 16, 16Aand 16B does not differ from the device depicted in FIGS. 13, 13A and13B. As a result, the atherectomy device in FIGS. 16, 16A and 16B hastwo relatively short reduced diameter segments 68, one being locatedjust proximal to the enlarged diameter section 28, and the other beinglocated just distal to the enlarged diameter section 28.

FIGS. 17, 17A and 17B depict a similar embodiment having two reduceddiameter segments 68 distal to the enlarged diameter tissue removalsection 28, and one reduced diameter segment 68 just proximal to theenlarged diameter section 28. FIG. 18 depicts yet another embodiment,this one having two reduced diameter segments 68 distal to the enlargeddiameter section 28, and two reduced diameter segments 68 proximal tothe enlarged diameter section 28.

Selection of the number and location of the reduced diameter segmentscan be made based on the performance characteristics desired. Preferablyat least one of such reduced diameter segments is located within aboutone inch from the enlarged diameter tissue removal section 28, and mostpreferably within about a quarter inch from such enlarged diametertissue removal section 28.

FIG. 19 shows an embodiment generally similar to the embodiment depictedin FIGS. 13--13B--5both the embodiment of FIG. 13 and the embodiment ofFIG. 19 include a drive shaft 20 having a distal section 60 with reducedinner and outer diameters, as well as a short segment 68, just proximalto the enlarged diameter section 28, which also has reduced inner andouter diameters. The embodiment of FIG. 19 differs, however, in that itis manufactured from a single strand of wire. Use of one wire strand (asopposed to multiple wire strands) facilitates manufacture of the deviceby spring coiling machine technology, such as that which is commerciallyavailable from, e.g., WMC WAFIOS Machinery Corp. of Branford, Conn.(affiliated with WAFIOS Maschinenfabrik GmbH & Co., of Reutlingen,Germany). Spring coiling machines are capable of coiling wire withoutthe use of a mandrel--hence, a wide variety of shapes can be coiledwithout the need to construct or remove a mandrel. The embodiment ofFIG. 19 utilizes slightly larger diameter wire (e.g., about 0.009-0.010inch diameter, whereas the embodiment of FIG. 13 can be made from wireas thin as about 0.006-0.007 inches). This gives the drive shaft 20(excluding the enlarged diameter tissue removal section 28) of thedevice of FIG. 19 a slightly larger outer diameter than thecorresponding portions of the drive shaft of the device of FIG. 13, butboth devices can be manufactured with drive shafts having the same innerdiameters.

FIGS. 20-23 show several related embodiments of the invention whichillustrate a unique performance characteristic of the rotationalatherectomy device of the invention. In FIG. 20 the enlarged diametertissue removal section 28 of the rotational atherectomy device has amaximum diameter (measured at line "m") equal to the distance from lined₁ to line d₂. The wire turns 31 of the proximal, generally conicalportion 30 of the drive shaft's enlarged diameter section 28 are shownin a moved position 31', the wire turns 31 expanding to this positionwhen they unwind under rotational load during use of the atherectomydevice. Rotational load on the drive shaft 20 in general (and on thegenerally conical portion 30, in particular) increases rapidly each timewhen the rotating abrasive segment of the drive shaft (i.e., the portionof the drive shaft covered with abrasive material 24) engages stenotictissue and consequently the torque applied to the proximal end of thedrive shaft by the turbine of the atherectomy device is opposed by thetorque of the frictional forces applied to the abrasive segment of thedrive shaft when it engages stenotic tissue.

In the embodiment of FIG. 20, the abrasive coating 24 covers not onlythe entire distal portion 40 of the enlarged diameter section 28 of thedrive shaft, but also a small portion of the enlarged diameter section28 which is proximal to line "m". Extending the coverage of the abrasivecoating 24 proximally of the line "m" results in a more substantialportion of the enlarged diameter tissue removal section 28 being usablefor tissue removal.

In FIG. 20, the physical configuration of the enlarged diameter section28 is designed so that, under load, wire turns 31 of the proximal,generally conical portion 30 of the enlarged diameter section 28 unwindto the extent that one or more of the wire turns near the distal end ofthe generally conical portion 30 reach a diameter equal to the "at rest"maximum diameter of the enlarged diameter tissue removal section 28(measured at line "m"). Typically it is not the most distal wire turn(s)of the generally conical portion 30 of the drive shaft that unwind most.This is because the most distal wire turn of the generally conicalportion 30 is located immediately proximally to the abrasive segment ofthe drive shaft. Since the wire turns of the abrasive segment of thedrive shaft are preferably fixed to each other, they are incapable ofunwinding. The wire turns of the abrasive segment are preferably bondedto one another by the binder 26 which secures the abrasive coating 24 tothe wire turns of the drive shaft.

FIG. 21 illustrates a modified embodiment in which the physicalconfiguration of the enlarged diameter section 28 is designed so thatunder typical load conditions at least some of the wire turns 31 of theproximal, generally conical portion 30 of the enlarged diameter section28 unwind to a diameter slightly larger than the "at rest" maximumdiameter of the enlarged diameter section 28 (again, measured at line"m"). In FIG. 21, the maximum diameter of the wire turns in the movedposition 31' is equal to the distance from line d₃ to line d₄.

This expansion under load of some of the wire turns of the proximal,generally conical portion 30 of the enlarged diameter tissue removalsection 28 to a diameter equal to or slightly larger than the "at rest"maximum diameter of the enlarged diameter section 28 tends to limitlateral (i.e., radial) tissue removal by the abrasive coating 24 to adiameter essentially equal to the maximum "at rest" diameter of theenlarged diameter section 28. That is, expansion of the generallyconical portion 30 provides a lateral (i.e., radial) shield to preventadjacent tissue from contacting the abrasive material 24 locatedimmediately distally of the expanded wire turns of the generally conicalportion 30. At any time the unwinding of the wire turns of the generallyconical portion 30 may be significantly reduced or eliminated bystopping the rotation of the turbine (thereby eliminating torque appliedto the proximal end of the drive shaft) or by slightly withdrawing thedrive shaft 20 (thereby reducing the torque of frictional forces betweenthe abrasive coating 24 and the stenotic tissue). Return of the wireturns of the generally conical portion 30 to their normal "at rest"diameter facilitates withdrawal of the enlarged diameter tissue removalsection 28 from the artery once the stenosis has been opened; desirablythe drive shaft 20 should continue to be rotated while it is withdrawn,though preferably at a significantly reduced rotational speed.

The degree of unwinding of the wire turns is dependent upon a number ofparameters including the diameter of the wire, the material from whichthe wire is made, the maximum diameter of the enlarged tissue removalsection 28, and the rotational load applied to the drive shaft. Therotational load applied to the drive shaft in turn depends on the torqueof the turbine and the drop in rotational speed which is permitted whenthe rotating abrasive segment engages stenotic tissue to be removed.Preferably all these parameters are adjusted so that the desired amountof unwinding of the wire turns is achieved when the tissue removalsection 28 of the drive shaft is gently advanced against the stenotictissue. In a device designed to operate, e.g., at a rotational speed inthe range of 150,000-190,000 rpm (devices having smaller diameter tissueremoval sections being operated at the higher end of this range, anddevices having larger diameter tissue removal sections being operated atthe lower end of this range) desirably the rotational speed of the driveshaft should not decrease by more than about 5,000 rpm under such gentleadvancement against stenotic tissue. Such relatively small drop in therotational speed of the drive shaft should not produce either excessiveheat at the atherectomy site or a substantial increase in the size ofthe tissue particles removed. This drop in rotational speed, however,allowed Applicants to achieve a practically useful amount of unwindingof the wire turns of the generally conical portion 30 of the drive shaftfor drive shafts having enlarged diameter segments 28 with maximumdiameters of about 2 mm or larger.

FIGS. 22 and 23 are similar to FIGS. 20 and 21, but differ in that theabrasive coating 24 in each of these embodiments covers only the distalportion 40 of the enlarged diameter section 28 of the drive shaft, anddoes not extend into the proximal generally conical portion 30 of theenlarged diameter section 28 of the drive shaft 20 (i.e., the abrasivecoating terminates at line "m", the location of the maximum "at rest"diameter of the enlarged diameter section 28).

FIG. 24 is similar to FIGS. 21 and 23 in that, under typical loadconditions, at least some of the wire turns 31 of the proximal,generally conical portion 30 of the enlarged diameter section 28 (and,in the FIG. 24 embodiment, some of the proximal wire turns of the distalportion 40 of the enlarged diameter section 28) unwind to a diameterslightly larger than both the "at rest" maximum diameter of the enlargeddiameter tissue removal section 28, and, more importantly, the maximumdiameter of the abrasive coating 24. This embodiment differs, however,from FIGS. 21 and 23 in that the abrasive coating 24 in this embodimentcovers only part of the distal portion 40 of the enlarged diametersection 28 of the drive shaft. In particular, the abrasive coatingcovers only a distal part of the enlarged diameter section's distalportion 40, the coating terminating at line "n" on FIG. 24. Because theabrasive coating 24 does not extend proximally beyond line "n", themaximum diameter of the abrasive coating 24 (i.e., the distance fromline d₁ to line d₂, as measured at line "n") is about equal to themaximum "at rest" diameter of the enlarged diameter section 28 (i.e.,the distance from line d₁ to line d₂, as measured at line "m"). Undertypical load conditions, however, the wire turns 31 of the enlargeddiameter section 28 at line "m" unwind to a diameter slightly largerthan the maximum diameter of the abrasive coating 24.

FIG. 25 shows in enlarged detail changes in the longitudinalcross-sectional profile of the enlarged diameter tissue removal section28 of the rotational atherectomy device depicted in FIG. 2. Wire turnsof the proximal portion 30 of the tissue removal section 28 havediameters that increase distally at a generally constant rate, therebyforming a generally conical proximal section. Wire turns of the distalportion 40 of the enlarged diameter section 28 have diameters thatgradually decrease distally thereby forming a generally convex distalportion 40 having a longitudinal cross-section with a first radius ofcurvature R₁. The enlarged diameter section includes an intermediatetransitional portion 42 between the generally conical proximal sectionand the generally convex distal portion, the transitional portion 42having wire turns with diameters that gradually decrease proximally,thereby forming a generally convex transitional portion 42 having alongitudinal cross-section with a second radius of curvature R₂ which issmaller than the first radius of curvature R₁. The transitional portion42 thus provides a smooth transition from the generally conical proximalportion 30 of the enlarged diameter section 28 to the convex distalportion 40 of the enlarged diameter section 28.

FIGS. 26 and 27 depict a rotational atherectomy device having anenlarged diameter tissue removal section 28 with a slightly differentlongitudinal cross-sectional profile. In this embodiment, the firstradius of curvature R₁ of the distal portion 40 of the tissue removalsection 28 is smaller than the second radius of curvature R₂ of theintermediate transitional portion 42 of the tissue removal section 28.

FIG. 28 depicts an enlarged diameter tissue removal section 28 of arotational atherectomy device having another different longitudinalcross-sectional profile. In this embodiment, the distal portion 40 ofthe enlarged diameter section 28 has an essentially hemisphericalconfiguration, directly abutting the proximal conical portion 30 (i.e.,there is no intermediate transitional portion).

FIG. 29 shows yet another variation of the longitudinal profile of anenlarged diameter tissue removal section 28, which employs a generallycylindrical transitional portion 44 between the hemispherical distalportion 40 and the conical proximal portion 30. It will be understoodthat other variations on these profiles may be readily constructed byone of ordinary skill in the art.

FIGS. 30A and 30B illustrate an advantage of the rotational atherectomydevice of the invention. The enlarged diameter tissue removal section 28of the device in FIG. 30A, e.g., may have a diameter of about 1.5 mm anda length of about 4.1 mm, and the enlarged diameter tissue removalsection 28 of the device in FIG. 30B, e.g., may have a diameter of about2.1 mm and a length of about 6.1 mm. Note that these two enlargeddiameter tissue removal sections are generally geometricallyproportional to one another, notwithstanding being of differentdiameters.

The ability to maintain such proportionality permits one to design andselect profiles of the tissue removing component based entirely ondesired performance characteristics, permitting the profile of thetissue removing component to be scaled up or down without destroying itsselected geometry. In contrast, certain prior art devices whichphysically attach a diamond coated rigid burr to a drive shaft (such asthose depicted in U.S. Pat. No. 4,990,134 (Auth)) require certainminimum thickness and length characteristics of the burr in order toassure adequate fixation of the burr to the drive shaft, thereforeplacing significant constraints on possible design profiles of suchtissue removing component of the atherectomy device.

FIGS. 31A and 31B illustrate two embodiments which each utilize anexternal coating of an abrasive material 24' (secured by a suitablebinder 26') on a portion of the distal end segment of the drive shaft 20to define a single abrasive segment 64 at the distal end of the driveshaft 20. These embodiments thus differ from the atherectomy devicedepicted in FIG. 11 in that the rotational atherectomy devices of FIGS.31A and 31B have no enlarged diameter section 28. The abrasive segment64 preferably has an outer diameter which decreases distally to define agenerally convex outer surface--preferably the inner diameter of thedistal end segment is generally constant, and, thus, it is thecross-sectional thickness of the wire turns of the abrasive segment 64which decreases distally to form the generally convex outer surface ofthe abrasive segment 64 of the drive shaft 20.

The embodiments of both FIGS. 31A and 31B include a thin, flexible, lowfriction sheath or coating. In FIG. 31A, the sheath or coating 23 is ofsuch a thickness that its outer diameter is approximately equal to themaximum (abrasive coated) outer diameter of the abrasive segment 64. InFIG. 31B, the sheath or coating 23' is thinner--i.e., it is of such athickness that its outer diameter is less than the maximum (abrasivecoated) outer diameter of the abrasive segment 64.

The single abrasive segment 64 of the drive shaft 20 enables therotating drive shaft of the atherectomy device in both of theseembodiments to be advanced across even a very tight stenosis. Such lowprofile atherectomy devices may be particularly useful in preparing avery tight stenosis for further opening by another atherectomy device,e.g., having an enlarged diameter tissue removal section 28 as describedabove, or for other medical procedures such as balloon angioplasty.

To enhance the visibility of atherectomy devices of the invention duringuse, it may be desirable to include markers that are substantially moreradio-opaque than stainless steel on various portions of the atherectomydevice. FIG. 32 illustrates use of a radio-opaque coating 80 depositedon the outer surface of wire turns 31 of a substantial portion of thedistal section 60 of the drive shaft 20. Suitable coatings may beobtained by deposition of platinum or other radio-opaque alloys. In FIG.33, the radio-opaque material 80 is shown as entirely encapsulating thewire turns 31 of a substantial portion of the distal section 60 of thedrive shaft 20 (but the radio-opaque material does not fixate adjacentturns 31 of the drive shaft to one another, thus preserving theflexibility of the distal section 60 of the drive shaft).

FIG. 34 illustrates a variation of FIG. 33 in which the radio-opaquematerial 80 deposited on the wire turns 31 of drive shaft's distalsection 60 uniformly covers the wire turns 31 except for the innersurface of the wire turns 31. Such a configuration may be obtained byfirst coating the wire turns 31 uniformly with the radio-opaque material80 and then removing that portion of the material which would otherwisereduce the inner diameter of the drive shaft lumen, therefore leavinggenerally flat inner surfaces 81 on the wire turns 31 as shown in thedrawing. Alternately a mandrel or similar device may be placed in thedrive shaft lumen before coating the wire turns 31 with radio-opaquematerial 80 so as to prevent reduction of the inner diameter of thisportion of the drive shaft by the radio-opaque material 80. Othersuitable manufacturing techniques may also be utilized.

FIG. 35 illustrates use of a marker in the form of a platinum or othersuitable radio-opaque collar 84 secured (such as by solder 86 or othersuitable material) to the distal end of the distal section 60 of thedrive shaft. The collar 84 includes a distal end having an opening 85with an inner diameter equal to or larger than the inner diameter of thedrive shaft lumen. The collar 84 provides good radiological imaging ofthe distal end of the rotational atherectomy device, and the solderattaching the collar 84 to the wire turns 31 also serves to secure thewire turns 31 of the distal end segment 64 of the drive shaft to oneanother.

FIGS. 36-41 depict alternative techniques for finishing the distal endsegment of the drive shaft. In FIGS. 36 and 37, the very distal ends ofthe wire turns 31 are first rounded off (as by machining) to the profiledepicted in FIG. 36. The distal end segment 64 is then coated with asuitable bonding material 87 to secure the wire turns 31 to one another(FIG. 37). Applicants have found that electro-deposition (i.e.,electroplating) of nickel provides desirable results. By masking theinner surfaces of the wire turns 31, nickel is electro-deposited only onthe outer surfaces of the wire turns 31 so that the inner diameter ofthe drive shaft 20 is not affected. The above-described masking may beaccomplished by filling the lumen of the drive shaft with a shaft orfilament made from tetrafluoroethylene or other suitable materials.

FIGS. 38 and 39 depict an alternative technique in which, rather thanrounding off the distal end of the drive shaft 20 (as is depicted inFIG. 36), the distal end of the drive shaft is simply trimmed off"square" and then electroplated as described above.

FIGS. 40 and 41 depict a particularly preferred technique in which thedistal end segment 64 is electroplated before being trimmed to itsfinished length, as shown in FIG. 40. After electroplating is completed,the drive shaft 20 is trimmed to its finished length and the distal endsegment 64 may be rounded off (as by machining) to form a generallyconvex outer surface of the distal end segment of the drive shaft, asdepicted in FIG. 41. This technique has the advantage that finalmachining of the distal end segment 64 to its finished profile is moreeasily accomplished when the wire turns 31 have been secured to oneanother by the electro-deposition material.

In any of the embodiments of FIGS. 36-41 the plating metal 87 mayoptionally include metals that are more radio-opaque than stainlesssteel. As noted above, nickel, which is somewhat more radio-opaque thanstainless steel, may be used as an electro-deposition metal. If desired,an overcoat of platinum (or other highly radio-opaque material) may bedeposited over the nickel layer, or may be sandwiched between successivelayers of nickel. Applicants have also found that electro-depositednickel may be used as a binder to secure abrasive material to the distalend segment 64, as described above, e.g., with reference to FIG. 9.

FIG. 42 depicts a rotational atherectomy device having a drive shaft 20with generally constant inner and outer diameters along most of itslength. It also has two distally tapered segments 69 and 69', one (69)being just proximal to the enlarged diameter section 28, and the other(69') being in the distal section 60 of the drive shaft 20. FIG. 43 is abroken-away, longitudinal cross-sectional view of a mandrel 50' whichmay be used to manufacture an atherectomy device having a drive shaft 20with the tapered profile depicted in FIG. 42. The mandrel 50' is similarin most respects to the mandrel 50 depicted in FIG. 8, except that itsmandrel shaft 52' is tapered distally along both a proximal section 46and a distal section 48, the intermediate section 47 having a generallyconstant diameter. Such mandrel shafts can be manufactured using, e.g.,computer controlled centerless grinding systems available from GlebarCompany of Franklin Lakes, N.J. The degree of taper is somewhatexaggerated in FIGS. 42-43 for illustrative purposes.

While a preferred embodiment of the present invention has beendescribed, it should be understood that various changes, adaptations andmodifications may be made therein without departing from the spirit ofthe invention and the scope of the appended claims.

What is claimed is:
 1. An atherectomy device comprising a flexible,elongated drive shaft having proximal and distal ends, the drive shaftnear its distal end, including an enlarged diameter tissue removalsection having proximal and distal portions and being comprised of atleast one helically wound wire, the proximal portion of the enlargediameter tissue removal section comprising the entire portion of theenlarged diameter tissue removal section that is proximal to a point ofmaximum diameter of the enlarged diameter tissue removal section, wireturns of the proximal portion of the tissue removal section havingdiameters that increase distally at a constant rate thereby forminggenerally the shape of a cone extending for the entire length or nearlythe entire length of the proximal portion of the tissue removal section,at least part of the tissue removal section having an abrasive surfacedefining an abrasive segment of the drive shaft.
 2. The atherectomydevice of claim 1 wherein wire turns of the distal portion of theenlarged diameter tissue removal section have diameters that graduallydecrease distally thereby forming a generally convex distal portion. 3.The atherectomy device of claim 1 wherein the tissue removal section ofthe drive shaft is comprised of two or more helically wound wires. 4.The atherectomy device of claim 1 wherein the abrasive surface covers atleast the distal portion of the tissue removal section.
 5. Theatherectomy device of claim 1 wherein the abrasive surface covers atleast part of the distal portion of the tissue removal section.
 6. Theatherectomy device of claim 1 wherein at least some of the wire turns ofthe abrasive segment of the drive shaft are secured to one another. 7.The atherectomy device of claim 1 wherein the abrasive surface comprisesan external coating of abrasive material including a binder for bondingthe abrasive material to wire turns of the drive shaft, the binder alsosecuring at least some of the wire turns of the abrasive segment of thedrive shaft to one another.
 8. The atherectomy device of claim 1 whereinsubstantially the entire length of the drive shaft is comprised of oneor more helically wound wires, such wire(s) being continuous with thewire(s) forming the enlarged diameter tissue removal section of thedrive shaft.
 9. The atherectomy device of claim 1 wherein wire turns ofthe distal portion of the enlarged diameter tissue removal section havediameters that gradually decrease distally thereby forming a generallyconvex distal portion having, in longitudinal cross-section, a firstradius of curvature.
 10. The atherectomy device of claim 9 wherein thetissue removal section includes an intermediate transitional portionhaving wire turns with diameters that gradually change so that suchtransitional portion forms a generally convex shape having, inlongitudinal cross-section, a second radius of curvature, therebyproviding a smooth transition from the generally conical proximalportion of the tissue removal section to the generally convex distalportion of the tissue removal section.
 11. The atherectomy device ofclaim 10 wherein the first radius of curvature of the distal portion ofthe tissue removal section is larger than the second radius of curvatureof the intermediate transitional portion of the tissue removal section.12. The atherectomy device of claim 10 wherein the first radius ofcurvature of the distal portion of the tissue removal section is smallerthan the second radius of curvature of the intermediate transitionalportion of the tissue removal section.
 13. The atherectomy device ofclaim 1 wherein the enlarged diameter tissue removal section includes anintermediate portion having wire turns with generally constant diametersthereby giving the intermediate portion a generally cylindrical shape.14. The atherectomy device of claim 1 wherein that section of theelongated drive shaft which is proximal to the enlarged diameter tissueremoval section has generally constant cross-sectional inner and outerdiameters along substantially its entire length except for a reduceddiameter segment located near the enlarged diameter tissue removalsection, such reduced diameter segment having both inner and outerdiameters reduced relative to immediately adjacent portions of the driveshaft.
 15. The atherectomy device of claim 14 further comprising alength of low-friction tubing disposed over the reduced diameter segmentand at least a substantial portion of the proximal section of the driveshaft, the portion of tubing disposed over the reduced diameter segmentof the drive shaft having an inner diameter less than the inner diameterof adjacent portions of the tubing, thereby securing the tubing againstlongitudinal movement with respect to the drive shaft.
 16. Theatherectomy device of claim 14 including two or more reduced diametersegments located close to one another, the most distal one of suchsegments being located near the enlarged diameter tissue removalsection.
 17. The atherectomy device of claim 16 further comprising alength of low-friction tubing disposed over the reduced diametersegments and at least a substantial portion of the proximal section ofthe drive shaft, the portions of tubing disposed over the reduceddiameter segments of the drive shaft having an inner diameter less thanthe inner diameter of adjacent portions of the tubing, thereby securingthe tubing against longitudinal movement with respect to the driveshaft.
 18. The atherectomy device of claim 14 wherein the reduceddiameter segment is located within about one inch from the enlargeddiameter tissue removal section.
 19. The atherectomy device of claim 14wherein the reduced diameter segment is located within about one quarterinch from the enlarged diameter tissue removal section.
 20. Theatherectomy device of claim 1 wherein that section of the elongateddrive shaft which is distal to the enlarged diameter tissue removalsection has generally constant cross-sectional inner and outer diametersalong substantially its entire length except for a reduced inner andouter diameter segment located near the enlarged diameter tissue removalsection.
 21. The atherectomy device of claim 20 further comprising alength of low-friction tubing disposed over the reduced diameter segmentand at least a substantial portion of the distal section of the driveshaft, the portion of tubing disposed over the reduced diameter segmentof the drive shaft having an inner diameter less than the inner diameterof adjacent portions of the tubing, thereby securing the tubing againstlongitudinal movement with respect to the drive shaft.
 22. Theatherectomy device of claim 20 including two or more reduced diametersegments located close to one another, the most proximal one of suchsegments being located near the enlarged diameter tissue removalsection.
 23. The atherectomy device of claim 22 further comprising alength of low-friction tubing disposed over the reduced diametersegments and at least a substantial portion of the distal section of thedrive shaft, the portions of tubing disposed over the reduced diametersegments of the drive shaft having an inner diameter less than the innerdiameter of adjacent portions of the tubing, thereby securing the tubingagainst longitudinal movement with respect to the drive shaft.
 24. Theatherectomy device of claim 20 wherein the reduced diameter segment islocated within about one inch from the enlarged diameter tissue removalsection.
 25. The atherectomy device of claim 20 wherein the reduceddiameter segment is located within about one quarter inch from theenlarged diameter tissue removal section.
 26. The atherectomy device ofclaim 1 wherein that section of the elongated drive shaft which isproximal to the enlarged diameter tissue removal section has generallyconstant cross-sectional inner and outer diameters along substantiallyits entire length except for a first reduced inner and outer diametersegment located proximally to the enlarged diameter tissue removalsection; and wherein that section of the elongated drive shaft which isdistal to the enlarged diameter tissue removal section has generallyconstant cross-sectional inner and outer diameters along substantiallyits entire length except for a second reduced inner and outer diametersegment located distally to the enlarged diameter tissue removalsection.
 27. The atherectomy device of claim 1 wherein that section ofthe elongated drive shaft which is proximal to the enlarged diametertissue removal section has generally constant cross-sectional inner andouter diameters along substantially its entire length; and wherein thatsection of the elongated drive shaft which is distal to the enlargeddiameter tissue removal section also has generally constantcross-sectional inner and outer diameters along substantially its entirelength, the inner and outer diameters of such distal section of thedrive shaft being smaller than the corresponding inner and outerdiameters of the proximal section of the drive shaft.
 28. Theatherectomy device of claim 1 wherein that section of the elongateddrive shaft which is proximal to the enlarged diameter tissue removalsection has generally constant cross-sectional inner and outer diametersalong substantially its entire length except for a reduced inner andouter diameter segment located proximal to the enlarged diameter tissueremoval section; the section of the elongated drive shaft which isdistal to the enlarged diameter tissue removal section having generallyconstant cross-sectional inner and outer diameters along substantiallyits entire length, the inner and outer diameters of such distal sectionof the drive shaft being smaller than the inner and outer diametersalong substantially the entire length of the proximal section of thedrive shaft.
 29. The atherectomy device of claim 1 wherein the driveshaft includes a distal end segment having a layer of electro-depositionmaterial securing adjacent wire turns of the drive shaft to one another.30. The atherectomy device of claim 29 wherein the electro-depositionmaterial is more radio-opaque than stainless steel.
 31. The atherectomydevice of claim 29 wherein the distal end segment has a distal most wireturn with an outer diameter which is less than an outer diameter of awire turn immediately proximal to such distal wire turn.
 32. Theatherectomy device of claim 31 wherein the inner diameter of the distalend segment is generally constant, the cross-sectional thickness of thewire turns of the distal end segment, in longitudinal cross-section,decreasing distally to form the generally convex outer surface of thedistal end segment of the drive shaft.
 33. The atherectomy device ofclaim 31 wherein at least a portion of the distal end segment isprovided with an external coating of an abrasive material to define asecond abrasive segment at the distal end of the drive shaft.
 34. Theatherectomy device of claim 1 wherein the elongated drive shaft includesa distal end segment having an outer diameter which, in longitudinalcrosssection, decreases distally to define a generally convex outersurface.
 35. The atherectomy device of claim 31 wherein the innerdiameter of the distal end segment is generally constant, thecross-sectional thickness of the wire turns of the distal end segment,in longitudinal cross-section, decreasing distally to form the generallyconvex outer surface of the distal end segment of the drive shaft. 36.The atherectomy device of claim 31 wherein at least a portion of thedistal end segment is provided with an external coating of an abrasivematerial to define a second abrasive segment at the distal end of thedrive shaft.
 37. An atherectomy device comprising a flexible, elongateddrive shaft, the drive shaft including an enlarged diameter tissueremoval section having proximal and distal portions and being comprisedof at least one helically wound wire, wire turns of the proximal portionof the tissue removal section having diameters that increase distally ata generally constant rate thereby forming generally the shape of a cone,wire turns of the distal portion of the enlarged diameter tissue removalsection have diameters that gradually decrease distally thereby forminga generally convex distal portion, at least part of the tissue removalsection having an abrasive surface defining an abrasive segment of thedrive shaft;that section of the elongated drive shaft which is proximalto the enlarged diameter tissue removal section having generallyconstant cross-sectional inner and outer diameters along substantiallyits entire length except for a reduced diameter segment located withinabout one inch from the enlarged diameter tissue removal section, suchreduced diameter segment having both inner and outer diameters reducedrelative to immediately adjacent portions of the drive shaft; thatsection of the elongated drive shaft which is distal to the enlargeddiameter tissue removal section having generally constantcross-sectional inner and outer diameters along substantially its entirelength, the inner and outer diameters of such distal section of thedrive shaft being smaller than the corresponding inner and outerdiameters of the drive shaft along substantially the entire length ofthe drive shaft proximal to the enlarged diameter tissue removalsection.
 38. An atherectomy device comprising a guide wire having agenerally constant cross-sectional diameter along substantially itsentire length; and a flexible, elongated drive shaft comprised of one ormore helically wound wires defining a central lumen in which the guidewire is disposed, the drive shaft including an enlarged diameter tissueremoval section; substantially the entire length of the drive shafthaving a generally constant cross-sectional inner diameter except forthe enlarged diameter tissue removal section and a reduced diametersegment located near the tissue removal section to function as a bearingto facilitate smooth rotation of the drive shaft about the guide wire,said reduced diameter segment being reduced relative to said generallyconstant cross-sectional inner diameter.
 39. The atherectomy device ofclaim 38 wherein the reduced diameter segment has both inner and outerdiameters reduced relative to immediately adjacent portions of the driveshaft.
 40. The atherectomy device of claim 39 further comprising alength of low-friction tubing disposed over the reduced diameter segmentand at least a substantial portion of the drive shaft, the portion oftubing disposed over the reduced diameter segment of the drive shafthaving an inner diameter less than the inner diameter of adjacentportions of the tubing, thereby securing the tubing against longitudinalmovement with respect to the drive shaft.
 41. The atherectomy device ofclaim 38 including two or more reduced diameter segments, at least onebeing located distally of the enlarged diameter tissue removal section,and at least one being located proximally of the enlarged diametertissue removal section.
 42. The atherectomy device of claim 38 includingtwo or more reduced diameter segments located proximally of the enlargeddiameter tissue removal section, the segments being located close to oneanother and the most distal one of such segments being located near theenlarged diameter tissue removal section.
 43. The atherectomy device ofclaim 38 including two or more reduced diameter segments locateddistally of the enlarged diameter tissue removal section, the segmentsbeing located close to one another and the most proximal one of suchsegments being located near the enlarged diameter tissue removalsection.
 44. The atherectomy device of claim 38 wherein the reduceddiameter segment is located within about one inch from the enlargeddiameter tissue removal section.
 45. The atherectomy device of claim 38wherein the reduced diameter segment is located within about one quarterinch from the enlarged diameter tissue removal section.
 46. Anatherectomy device comprising a flexible, elongated drive shaft, thedrive shaft including an enlarged diameter tissue removal section havinga generally conical proximal portion and a generally convex distalportion, the drive shaft being comprised of at least one helically woundwire, at least part of the distal portion of the enlarged diametertissue removal section including an external coating of an abrasivematerial secured to the wire turns of the drive shaft to define anabrasive segment of the drive shaft, at least a substantial portion ofthe wire turns of the abrasive segment, including the more proximal wireturns of the abrasive segment, being secured to one another; the maximumouter diameter and length of the abrasive segment being selected sothat, at operational rotational speeds and under load, at least some ofthe wire turns of the proximal portion of the enlarged diameter tissueremoval section unwind from their at-rest diameter to an effective outerdiameter which is at least as large as the maximum outer diameter of theabrasive segment.
 47. The atherectomy device of claim 46, wherein themaximum outer diameter and length of the abrasive segment being selectedso that, at operational rotational speeds and under load, at least someof the wire turns of the proximal portion of the enlarged diametertissue removal section unwind from their at-rest diameter to aneffective outer diameter which is larger than the maximum outer diameterof the abrasive segment.